Meal Stimulating After Roux-en Y Gastric Bypass

July 6, 2011 updated by: Hvidovre University Hospital

In many studies, gastric bypass surgery led to total remission of type 2 diabetes (T2DM) as early as 1 - 2 days after surgery before any real weight loss has occurred. This suggests that the remission of the T2DM is due to the direct effect of the operation, more than the secondary effect of the weight loss. The reasons for the major effect on the glucose metabolism after gastric bypass surgery are still unaccounted for.

The aim of this project will be to unveil some of the mechanisms that explain the effect of gastric bypass surgery on the glucose metabolism. Further more to find a better way of testing patients that have just undergone gastric bypass surgery. It is not possible to test patients who have just undergone gastric bypass surgery with normal oral glucose tolerance test (OGTT) and a normal meal, because patients can only take in fluid and a normal OGTT will often lead to dumping. Instead we will try to modify these tests - OGTT with lower glucose level and meal-testing with a protein drink.

The hypothesis of the study is that the investigators can see changes in different hormones and adipokines before and after surgery, even with modified OGTT and meal testing. The project will consist of clinical trials on patients without T2DM that will undergo gastric bypass surgery. The studies will take place before and within the first week after surgery. The investigators will measure different hormones and adipokines after OGTT and a meal with a protein drink. The investigators expect to see significant changes in some of the analyses after the operation in patients undergoing gastric bypass.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Obese with BMI > 40 undergoing gastric bypass surgery or obese with BMI > 35 with complications of their obesity in form of high blood pressure or other related complications undergoing gastric bypass surgery.

Description

Inclusion Criteria:

  • Obese with BMI> 40 undergoing gastric bypass surgery OR
  • Obese with BMI > 35 with complications of their obesity in form of high blood pressure or other related complications undergoing gastric bypass surgery
  • Age between 20-60 years

Exclusion Criteria:

  • Age > 60
  • Diabetes
  • Psychiatric illness
  • Mentally challenged
  • Addiction
  • Serious cardiac or lung diseases
  • Diseases in the abdomen
  • Other serious illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients without diabetes undergoing gastric bypass
Procedure: gastric bypass surgery and testing
The patients will be tested with OGTT and meal testing before and after undergoing gastric bypass surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Collaborators

Novo Nordisk A/S
University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (ESTIMATE)

June 8, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 8, 2011

Last Update Submitted That Met QC Criteria

July 6, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-C-2007-0108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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